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| ID | Type | Description | Link |
|---|---|---|---|
| ACR0906 |
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The primary objective to this study is to describe the auditory development and performance of young deaf children who receive bilateral implants during the first two years following device activation.
The primary purpose of this study is to track patient outcomes for bilateral cochlear implant recipients in a cohort of children, ages 12 to 36 months at time of surgery, who receive two implants in the same operation or in two different surgeries with the initial fitting of the devices separated by no more than six months. Acquisition of auditory milestones and speech recognition skills, which underpin the development of spoken language, will be assessed on a battery of outcome measures typically used to quantify implant benefits. In addition, global quality of life and communicative performance will be assessed by parental proxy. Performance will be tracked after 3, 6, 12, 18, and 24 months of device use. The study also will identify variables that may predict the degree of bilateral implant benefit in young children (e.g., age at implant, pre-implant hearing thresholds, communication mode, family socioeconomic status, post-implant aided thresholds, simultaneous vs. staged placement of devices).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HiResolution Bionic Ear System (Cochlear Implant) | Device | Subjects are required to have bilateral implantation of the Advanced Bionics HiResolution Bionic Ear System (Cochlear Implant) |
| Measure | Description | Time Frame |
|---|---|---|
| Subject performance on speech perception tests | Two years post device activation |
| Measure | Description | Time Frame |
|---|---|---|
| Speech recognition performance at various intervals. Global quality of life and functional communicative performance completed by parental proxy | 3, 6, 12, 18, and 24 months post device activation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Lustig, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| ID | Term |
|---|---|
| D003638 | Deafness |
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D003054 | Cochlear Implants |
| ID | Term |
|---|---|
| D058117 | Neural Prostheses |
| D058542 | Implantable Neurostimulators |
| D004567 | Electrodes, Implanted |
| D004566 | Electrodes |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D055615 |
| Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D019736 | Prostheses and Implants |
| D006310 | Hearing Aids |
| D012682 | Sensory Aids |